Cleared Traditional

K945569 - GCII AGAR WITH ISOVITALX ENRICHMENT

K945569 is the FDA 510(k) clearance for GCII AGAR WITH ISOVITALX ENRICHMENT by Becton Dickinson Microbiology Systems. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K945569 · Becton Dickinson Microbiology Systems · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
114d
Days
Class 2
Risk

K945569 is an FDA 510(k) clearance for the GCII AGAR WITH ISOVITALX(R) ENRICHMENT. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on February 2, 1995 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K945569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1994
Decision Date February 02, 1995
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 102d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 31
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K945569.
BBLCHROMAGAR MRSA
K042812 · Becton, Dickinson & CO · Nov 2004
BHI W/VANCOMYCIN AGAR
K964560 · Hardy Diagnostics · Jan 1997
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995
SYNERGY QUAD
K941443 · Remel Co. · Sep 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems · Sep 1993